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Completed

NCT Number: NCT01484873

Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor

The purpose of this study is to determine whether exenatide can cause weight loss in patients with a history of craniopharyngioma or other brain lesion.

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Key information

Conditions

Obesity Body Weight Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniopharyngioma Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gonadal Disorders Gonadal Dysgenesis Hypogonadism Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sexual Infantilism Signs and Symptoms Urogenital Abnormalities Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanderbilt University

Nashville, Tennessee, 37232, United States

About this study

Hypothalamic obesity occurs in up to 60% of patients with tumors in the hypothalamic region, most commonly craniopharyngiomas. Hypothalamic dysfunction can be due to tumor infiltration and as a consequence of surgery or radiation therapy. Survivors who develop obesity have greater morbidity and mortality than normal weight survivors. Prevention and treatment of obesity in this population is vital in order to decrease the morbidity and mortality from diabetes, stroke and myocardial infarction.

Exenatide (Byetta®) is a GLP-1 homologue that was FDA approved for treatment of type 2 diabetes in 2005. It also decreases the rate of gastric emptying and increases satiety and has been shown to cause weight loss in some people. Exenatide may improve insulin sensitivity and satiety in patients with hypothalamic obesity but without the risks of bariatric surgery. The investigators hypothesize that treatment with exenatide will lead to weight loss in patients with hypothalamic obesity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 40 years old
  • History of craniopharyngioma or other lesion in the hypothalamic region
  • Greater than 6 months post-treatment, including chemotherapy, surgery or radiation
  • BMI >30 mg/m2
  • Females must be post-menopausal, surgically sterile or using effective birth control for at least 12 weeks

Exclusion criteria

  • HgbA1C >7%
  • Use of diabetes medications other than metformin in the past 12 weeks, including exenatide
  • Use of weight loss drugs or initiation of a weight loss program in past 3 months
  • Impaired renal function or history of kidney transplant
  • History of gall stones (unless s/p cholecystectomy), pancreatitis or alcoholism
  • Personal or family history of medullary carcinoma of the thyroid or MEN type 2
  • History of gastroparesis or other gastric motility problems as exenatide decreases gastric motility
  • History of allergic reaction to exenatide or other medication components
  • Other significant comorbidities other than pituitary deficiencies
  • Currently prescribed warfarin (exenatide may alter warfarin metabolism)
  • Pregnant or lactating females
  • History of severe hypoglycemia (BG <60 and requiring assistance from another person)

Treatment and study plan

exenatide

Drug

Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.

Other names: Byetta

Primary outcomes

  1. Body Weight (kg)

    Time frame: baseline, 50 weeks

    Change in body weight from baseline to end of study

Secondary outcomes

  1. Resting Energy Expenditure (Kcals Per Day)

    Time frame: baseline, 50 weeks

    Change in resting energy expenditure from baseline to 50 weeks

  2. Visual Analogue Scales for Post-meal Satiety

    Time frame: baseline, 50 weeks

    Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).

  3. Insulin Secretion (Area Under the Curve)

    Time frame: baseline, 50 weeks

    Change in insulin secretion from baseline

  4. Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)

    Time frame: baseline, 50 weeks

    Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2011
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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